Genetic and Non-Genetic Breast Cancer Risk Prediction Evaluation in Indonesian Samples

NCT05570266 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 322

Last updated 2023-09-13

No results posted yet for this study

Summary

Breast cancer is the most common cancer and cause of cancer- related deaths among women, accounting for 1.67 million (25.2%) new cases and 521,907 (14.7%) deaths worldwide. The prevalence and survival rates of breast cancer differ per country. In Indonesia, majority of patients (70.9%) go to the clinic with advanced stages of breast cancer. Five-year survival rate is 51.07%. One of the most important determinants of survival is education level and stage of breast cancer.

Current screening methods include mammography and radiology assessments, both of which have disadvantages specifically in Asian population. Mammography is less useful in Asian population because the population has denser breast, resulting to failure to diagnose cases of breast cancer in this population in 37-70% of cases. Moreover, screening methods provide binary answers, and therefore does not inform risk profile of the patients.

The investigators aim to implement PRS into the breast cancer screening process while observing the differences of genetic and non-genetic risk factor in patients with breast cancer and patients without any medical/family history of breast cancer in Indonesian population.

Conditions

Interventions

DIAGNOSTIC_TEST

Breast Cancer Risk Prediction Software

Genotyping of known breast cancer-related markers (313 variants) will be conducted using a microarray genotyping chip (Genetic Risk). Survey answers will determine Gail Model scores and thus Clinical Risk Score.

Sponsors & Collaborators

  • SJH Initiatives

    collaborator UNKNOWN
  • MRCCC Siloam Hospitals Semanggi

    collaborator UNKNOWN
  • Nalagenetics Pte Ltd

    lead INDUSTRY

Principal Investigators

  • Samuel Haryono, MD, PhD · SJH Initiatives

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-13
Primary Completion
2023-01-10
Completion
2023-05-25

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05570266 on ClinicalTrials.gov